Devices

Global Medical Production Warning Letter

A 7/15-7/30 FDA inspection at Global Medical Production, Jiaxing, China, determined that its sterile and non-sterile electrosurgical scissors, sterile electrosurgical graspers, and sterile veress pneumoperitoneum needles are adulterated due to Quality System Regulation violations. A recently-released 11/16 Warning Letter says specific violations were:

failing to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
failing to establish and maintain procedures to control product that does not conform to specified requirements;
failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure;
failing to conduct periodic inspections per established procedures to ensure adherence to applicable equipment maintenance schedules;
failing to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria;
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to maintain device master records; and
failing to maintain device history records.

The letter says the firm’s responses to six of the observations were inadequate and the adequacy of its responses to the other two observations could not be determined.

The inspection also found that the firm’s devices are misbranded because the company failed or refused to furnish required Medical Device Reporting information by failing to develop, maintain, and implement a Medical Device Reporting procedure.

Global Medical was told to respond with a list of specific steps it has taken to address the noted violations and prevent their recurrence, with documentation of the corrections and/or corrective actions the firm has taken and a timetable for completing the corrections.

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